Assistant Manager, Quality Control
Amneal Pharmaceuticals · Bharuch · onsite · Posted 40d ago
Undisclosed12–17 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
The Deputy Manager - Quality Control is responsible for managing laboratory operations, stability studies, and quality systems to ensure compliance with regulatory and cGMP standards. The role involves oversight of preventive maintece, calibration, GLP adherence, documentation review, and data integrity across QC functions. It also includes handling deviations, OOS investigations, change controls, and driving continual improvement through training and SOP implementation.
To ensure the integrity, accuracy, and compliance of Quality Control investigations and documentation through effective review and oversight of Out of Specification (OOS), Out of Trend (OOT), and other quality events. This role ensures adherence to regulatory guidelines, Good Laboratory Practices (GLP), and internal SOPs to support continuous improvement in laboratory quality systems.
- Plan and supervise preventive maintece, calibration, and verification of QC instruments.
- Ensure timely release of raw materials, intermediates, and packing materials as per approved specifications.
- Maintain strict compliance with GLP, safety protocols, and laboratory housekeeping.
- Prepare and review stability protocols, monitor sample charging/withdrawal, and approve stability reports.
- Investigate deviations, OOS, OOAL, and incidents; implement effective CAPA.
- Review and approve QC-related change controls, SOPs, and specifications.
- Conduct audit trail reviews and ensure electronic data integrity for software-enabled instruments.
- Oversee LIMS operations and ensure accurate documentation and traceability.
- Identify training needs and support skill development for QC personnel.
- Manage analytical column inventory and laboratory standards as per SOPs.
- Ensure timely release of raw materials, intermediates, and packing materials as per approved specifications.
- Maintain strict compliance with GLP, safety protocols, and laboratory housekeeping.
- Prepare and review stability protocols, monitor sample charging/withdrawal, and approve stability reports.
- Investigate deviations, OOS, OOAL, and incidents; implement effective CAPA.
- Review and approve QC-related change controls, SOPs, and specifications.
- Conduct audit trail reviews and ensure electronic data integrity for software-enabled instruments.
- Oversee LIMS operations and ensure accurate documentation and traceability.
- Identify training needs and support skill development for QC personnel.
- Manage analytical column inventory and laboratory standards as per SOPs.
- M.Sc / M.Pharm / B.Pharm - Chemistry or related discipline preferred.
Experience:
- 12+ years of experience in QC operations within API manufacturing.
Skills:
- GLP GDP Compliance - Advanced
- Stability Study Management - Advanced
- Data Integrity LIMS Operations - Advanced
- Deviation/OOS Investigation - Advanced
- Regulatory Compliance Documentation - Advanced
- Leadership People Development - Advanced
Experience:
- 12+ years of experience in QC operations within API manufacturing.
Skills:
- GLP GDP Compliance - Advanced
- Stability Study Management - Advanced
- Data Integrity LIMS Operations - Advanced
- Deviation/OOS Investigation - Advanced
- Regulatory Compliance Documentation - Advanced
- Leadership People Development - Advanced
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
API ManufacturingCGMPpeople developmentChemistryCAPAQuality Systemslaboratory operationsLaboratory standardsQuality ControlManufacturingoperationsmaintenancePreventive MaintenancecomplianceQCHousekeeping
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
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1,455 reviews
4.2/ 5
Culture
4.0
Career growth
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Work-life
4.2
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